Johnson & Johnson’s (JNJ) consumer group announced a voluntary nationwide recall of 574,000 grape-flavored infants’ Tylenol bottles, citing dosing system complaints.
The McNeil Consumer Healthcare Division of J&J is recalling seven lots of the oral suspension, one ounce Tylenol at both the retail and wholesale levels.
The pullback of the over-the-counter pain reliever is a precautionary move after receiving a small number of complaints from consumers who reported difficulty using the drug’s SimpleMeasure dosing system.
The system includes a dosing syringe, which a caregiver inserts into a protective cover, or “flow restrictor,” at the top of the bottle to measure to proper dose.
In some cases, the flow restrictor was pushed into the bottle when inserting the syringe.No adverse events have been reported and J&J said the risk that this could cause a serious adverse medical event in infants is low.
McNeil said consumers can continue to use the product provided the flow restrictor at the top of the bottle remains in place. Otherwise, they can request a refund.
The unit of J&J has had to recall hundreds of thousands of Tylenol bottles over the last few years for various problems.
In 2011, dozens of Tylenol 8-Hour Extended Release lots manufactured at its plant in Fort Washington, Pa., were recalled due to complaints of a moldy odor.